Study Status

Description Value
Nickname Protocol Nickname
Study Status Active
Participants Enrolled 50
Sites Enrolled 154
Description Value
Protocol Row Id 1-1G9113
Studyid AA-AA-000-0000
Protocol Title Protocol Title
Nickname Protocol Nickname
Protocol Type Investigator Sponsored
Phase P3
Num Plan Site 190
Num Site Actl 176
Est Fpfv 2003-01-01
Act Fpfv 2003-01-01
Est Lplv 2021-06-01
Act Lplv 2021-06-01
Est Lpfv 2020-06-01
Act Lpfv 2020-06-01
Study Status Active
Num Plan Subj 1300
Num Enrolled Subj M 1301
Protocol Indication Protocol Indication
Product Product
Therapeutic Area Therapeutic Area
Protocol Product Number 123
X Rbm Flg Y
Participants Enrolled 50
Sites Enrolled 154

Study Overview

0 Red KRIs
1 Amber KRIs

Summary Charts

Group Overview

As of 2012-12-31, AA-AA-000-0000 has 50 participants enrolled across 154 countries. 0 Site-KRI combinations have been flagged across 0 countries as shown in the Study Overview Table above.
  • 0 countries have at least one red KRI
  • 1 countries have at least one red or amber KRI
  • 3 countries have neither red nor amber KRIS and are not shown

Results

Adverse Event Rate

Summary Charts

Summary
KRI Metric
KRI Score
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
China 41 11865 213145 0.06 -1.37
KRI Score
KRI Metric
Numerator


Serious Adverse Event Rate

Summary Charts

Summary
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
KRI Score
[1] “Nothing flagged for this KRI.”
Metric Table
[1] “Nothing flagged for this KRI.”
Nothing flagged for this KRI.
KRI Score
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
Numerator
[1] “Nothing flagged for this KRI.”


Non-Important Protocol Deviation Rate

Summary Charts

Summary
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
KRI Score
[1] “Nothing flagged for this KRI.”
Metric Table
[1] “Nothing flagged for this KRI.”
Nothing flagged for this KRI.
KRI Score
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
Numerator
[1] “Nothing flagged for this KRI.”


Important Protocol Deviation Rate

Summary Charts

Summary
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
KRI Score
[1] “Nothing flagged for this KRI.”
Metric Table
[1] “Nothing flagged for this KRI.”
Nothing flagged for this KRI.
KRI Score
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
Numerator
[1] “Nothing flagged for this KRI.”


Grade 3+ Lab Abnormality Rate

Summary Charts

Summary
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
KRI Score
[1] “Nothing flagged for this KRI.”
Metric Table
[1] “Nothing flagged for this KRI.”
Nothing flagged for this KRI.
KRI Score
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
Numerator
[1] “Nothing flagged for this KRI.”


Study Discontinuation Rate

Summary Charts

Summary
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
KRI Score
[1] “Nothing flagged for this KRI.”
Metric Table
[1] “Nothing flagged for this KRI.”
Nothing flagged for this KRI.
KRI Score
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
Numerator
[1] “Nothing flagged for this KRI.”


Treatment Discontinuation Rate

Summary Charts

Summary
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
KRI Score
[1] “Nothing flagged for this KRI.”
Metric Table
[1] “Nothing flagged for this KRI.”
Nothing flagged for this KRI.
KRI Score
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
Numerator
[1] “Nothing flagged for this KRI.”


Query Rate

Summary Charts

Summary
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
KRI Score
[1] “Nothing flagged for this KRI.”
Metric Table
[1] “Nothing flagged for this KRI.”
Nothing flagged for this KRI.
KRI Score
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
Numerator
[1] “Nothing flagged for this KRI.”


Outstanding Query Rate

Summary Charts

Summary
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
KRI Score
[1] “Nothing flagged for this KRI.”
Metric Table
[1] “Nothing flagged for this KRI.”
Nothing flagged for this KRI.
KRI Score
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
Numerator
[1] “Nothing flagged for this KRI.”


Outstanding Data Entry Rate

Summary Charts

Summary
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
KRI Score
[1] “Nothing flagged for this KRI.”
Metric Table
[1] “Nothing flagged for this KRI.”
Nothing flagged for this KRI.
KRI Score
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
Numerator
[1] “Nothing flagged for this KRI.”


Data Change Rate

Summary Charts

Summary
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
KRI Score
[1] “Nothing flagged for this KRI.”
Metric Table
[1] “Nothing flagged for this KRI.”
Nothing flagged for this KRI.
KRI Score
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
Numerator
[1] “Nothing flagged for this KRI.”


Screen Failure Rate

Summary Charts

Summary
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
KRI Score
[1] “Nothing flagged for this KRI.”
Metric Table
[1] “Nothing flagged for this KRI.”
Nothing flagged for this KRI.
KRI Score
[1] “Nothing flagged for this KRI.”
KRI Metric
[1] “Nothing flagged for this KRI.”
Numerator
[1] “Nothing flagged for this KRI.”


Metric Details

Type ID GroupLevel Abbreviation Metric Numerator Denominator Model AnalysisType Score Threshold nMinDenominator Priority Output Name Description MetricID
Analysis cou0001 Country AE Adverse Event Rate Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -2,-1,2,3 30 0 NA NA NA Analysis_cou0001
Analysis cou0002 Country SAE Serious Adverse Event Rate Serious Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -2,-1,2,3 30 0 NA NA NA Analysis_cou0002
Analysis cou0003 Country PD Non-Important Protocol Deviation Rate Non-Important Protocol Deviations Days on Study Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30 0 NA NA NA Analysis_cou0003
Analysis cou0004 Country PD Important Protocol Deviation Rate Important Protocol Deviations Days on Study Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30 0 NA NA NA Analysis_cou0004
Analysis cou0005 Country LB Grade 3+ Lab Abnormality Rate Grade 3+ Abnormal Labs Samples Total Lab Samples Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30 0 NA NA NA Analysis_cou0005
Analysis cou0006 Country SDSC Study Discontinuation Rate Subjects Discontinued - Study Enrolled Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3 0 NA NA NA Analysis_cou0006
Analysis cou0007 Country TDSC Treatment Discontinuation Rate Subjects Discontinued - Treatment Enrolled Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3 0 NA NA NA Analysis_cou0007
Analysis cou0008 Country QRY Query Rate Queries Total Data Points Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30 0 NA NA NA Analysis_cou0008
Analysis cou0009 Country OQRY Outstanding Query Rate Queries Open > 30 Days Total Queries Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30 0 NA NA NA Analysis_cou0009
Analysis cou0010 Country ODAT Outstanding Data Entry Rate Data Pages Entered > 10 Days Total Data Pages Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30 0 NA NA NA Analysis_cou0010
Analysis cou0011 Country CDAT Data Change Rate Data Points with 1+ Change Total Data Points Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30 0 NA NA NA Analysis_cou0011
Analysis cou0012 Country SF Screen Failure Rate Screen Failures Screened Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3 0 NA NA NA Analysis_cou0012